FDA 510(k) Application Details - K140723

Device Classification Name System, X-Ray, Mobile

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510(K) Number K140723
Device Name System, X-Ray, Mobile
Applicant ARIBEX, INC.
744 SOUTH 400 EAST
Orem, UT 84097 US
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Contact CHRISTOPHER DODGE
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Regulation Number 892.1720

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Classification Product Code IZL
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Date Received 03/21/2014
Decision Date 08/19/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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